Kornimate/medical-research-clean huggingface dataset:
clinical safety & efficacy of a new infant formula with specific medical purpose containing human milk oligosaccharides

Conditions: Cow's Milk Protein Allergy

Summary: the primary objective of the study is to show that infants with cow milk protein allergy (cmpa) fed with a new fsmp infant formula with reduced level of protein \& with 2 human milk oligosaccharides (hmos) (test formula) have a growth in line with infants fed with a comparable fsmp formula but without hmos (control formula). the secondary objectives are to assess whether consumption of test formula by cmpa infants (i) reduces medication use and risk for infections in particular lower respiratory tract infections/morbidity, (ii) is well tolerated and allows for age appropriate growth and (iii) reduces health care costs.

infants with physician diagnosed cmpa, aged between birth and 6 months of age will take either the control or new test infant formula for 4 months and if judged suitable by physician, up to maximum of 12 months of age. growth, adverse events, medication use and tolerance to formula will be assessed. as part of exploratory objectives, the study will also explore possible mode of action of the test formula in cmpa infants, by assessing whether consumption of test formula by cmpa infants affects stool microbiota and metabolic signatures as well as urine metabolic signatures and whether such changes can be associated to the intestinal inflammatory/health status, and the clinical measures.

Eligibility criteria:
inclusion criteria: 1. full term infant (37 weeks ≤ gestation ≤ 42 weeks) 2. 2500g ≤ birth weight ≤ 4500g 3. written informed consent. 4. infant aged between birth and 6 months. 5. not being breastfed at time of enrollment or mothers of cmpa infant doing breastfeeding and independently elected before enrollment to exclusively formula feed. 6. infants with physician diagnosed (and untreated with extensively hydrolysed or amino acid infant formula) cow milk protein allergy as per standard clinical practice and with at least 2 protocol specified symptoms present. exclusion criteria: 1. prior treatment with extensively hydrolysed infant formula for more than 72 hours or with amino acid infant formula. 2. congenital illness or malformation that may affect growth. 3. demonstrated chronic malabsorption not due to cmpa. 4. significant pre-natal and/or serious post-natal disease other than cmpa before enrollment (per investigator's medical decision). 5. minor parent(s). 6. infants whose parents or caregivers cannot be expected to comply with study procedures. 7. currently participating or having participated in another clinical trial since birth.
a randomized, controlled study of the safety and preventive efficacy of oral ganciclovir when used in conjunction with an intravitreal ganciclovir implant in the treatment of cytomegalovirus retinitis

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (cmv) disease in aids patients with unilateral cmv retinitis treated with an intravitreal ganciclovir implant. to compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (iv) ganciclovir therapy.

patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or iv ganciclovir.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * topical drugs and ophthalmics. patients must have: * aids. * unilateral cmv retinitis. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease. * ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography. * acute retinal necrosis or any other intraocular condition that might preclude study completion. * ocular condition requiring immediate surgery. * unable to have long-term iv catheter placement. concurrent medication: excluded: * vidarabine. * amantadine hydrochloride. * cytarabine. * fiac or fiau. * idoxuridine. * ribavirin. * valacyclovir. * foscarnet. * cmv hyperimmune globulin. * soluble cd4. * trichosanthin. * imipenem-cilastatin. * isoprinosine. * levamisole. * interferon. * other investigational drugs. patients with the following prior conditions are excluded: * history of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated. * history of hypersensitivity to acyclovir or ganciclovir. prior medication: excluded: * any prior oral ganciclovir in a cmv retinitis treatment protocol or more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment). * prior intravitreal ganciclovir implant. * more than two prior induction dose courses of iv anti-cmv therapy (per amendment). * intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).

Keywords: retinitis ganciclovir administration, oral acquired immunodeficiency syndrome
concentrations of maraviroc in the semen of hiv-infected men

Conditions: Maraviroc Concentrations in Semen

Summary: the objective of this study is to determine if concentrations of maraviroc in semen exceed the 50% and 95% inhibitory concentrations of hiv during the dose interval. the secondary objective is to determine the extent of maraviroc penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of maraviroc in semen, and to determine the variability in the penetration of maraviroc into the seminal compartment over the maraviroc dosing period.

the patient population will consist of 12 male hiv-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. patients will be enrolled from one clinic in downtown toronto and a hospital affiliated hiv specialty clinic in ottawa, ontario. eligible patients will have evidence of full virologic suppression (hiv viral load \< 50 copies/ml) at least one month prior to enrollment in the study. no changes will be made to the patients antiretroviral therapy during the course of the study.

Eligibility criteria:
inclusion criteria: * hiv infected male * 18 years old or older * on maraviroc twice daily as part of their antiretroviral regimen for at least 3 months prior to screening * viral load \< 50 copies/ml at least one month prior to enrolling * able to read, understand and sign a written informed consent prior to initiation of the study * medically stable at the time of the study, with no evidence of acute illness exclusion criteria: * having difficulty adhering to current antiretroviral therapy * patient is expected to have difficulties adhering with study protocol * patients with malignancy, or acute renal or liver disease * patient with active aids-defining illness * patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent * patient with any of the following abnormalities at the time of screening: * hemoglobin \< 85 g/l * absolute neutrophil count \< 1000 cells/ul * platelet count \< 50,000 cells/ul * ast, alt or total bilirubin \> 3 times the upper limit of normal * serum creatinine \> 1.5 times upper limit of normal * patient receiving concomitant therapy with rifampin or st. john's wort
a comparison of the effects of tiotropium inhalation qd and salmeterol inhalation bid on arterial blood gases.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to evaluate changes in pao2 following inhalation of tiotropium by handihaler compared to salmeterol mdi in patients with moderate to severe copd.


Eligibility criteria:
improving metoclopramide prescribing practices at penn through a physician-targeted intervention

Conditions: Gastroesophageal Reflux Disease; Diabetic Gastroparesis

Summary: the investigators hypothesized that: 1) an intervention targeted at the prescribing physician would increase the rate of a metoclopramide discontinuation among patients prescribed the medication for questionable or unclear indications; and 2) the discontinuation would be durable.


Eligibility criteria:
inclusion criteria: * physicians at university of pennsylvania health system who ordered an active metoclopramide prescription with a questionable indication. exclusion criteria: * physicians-in-training (e.g., residents, fellows) * physicians how were investigators on this study * physicians serving on the the university of pennsylvania drug use and effects committee or information technology oversight board

Keywords: metoclopramide randomized controlled trial
improving intermediate risk management. mark study

Conditions: Myocardial Infarction; Angina Pectoris; Stroke; Peripheral Arterial Disease

Summary: cardiovascular risk functions fail to identify more than 50% of patients who develop cardiovascular disease. this is especially evident in the intermediate-risk patients in which clinical management becomes difficult. the purpose of this study is to analyze if ankle-brachial index (abi), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.

primary prevention of cardiovascular diseases is a priority in public health policy of developed and developing countries. the fundamental strategy consists in identifying people in a high risk situation in which preventive measures are effective and efficient. however, specificity and sensitivity of risk equations are modest, which means that approximately 50% of the patients who are likely to develop a vascular event and would benefit from preventive measures are not considered at high risk. while 30% of the subjects considered at risk don't really benefit from preventive measures. moreover, decisions which imply thousands of people and can determine drug treatment indications are taken every day in primary care centers. these decisions are based mostly on the result of estimations about the probability to develop a vascular disease in 10 years. improvement of these predictions in our country will have an immediate, clinical and welfare impact and a short term public health effect. the purpose of this study is to analyze if ankle-brachial index (abi), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.

Eligibility criteria:
inclusion criteria: * population aged 35 to 74 which have an intermediate cardiovascular risk. exclusion criteria: * terminal illness or institutionalization at the appointment time * personal history of atherosclerotic disease
a study comparing aczone® plus differin® versus duac® plus differin® in patients with severe facial acne

Conditions: Acne Vulgaris

Summary: a study comparing the topical application of aczone® plus differin® versus duac® plus differin® in patients with severe facial acne (facial acne vulgaris).


Eligibility criteria:
inclusion criteria: * severe facial acne (acne vulgaris) exclusion criteria: * history of significant anemia or hemolysis * history of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis) * history of lupus, rosacea, or seborrheic dermatitis
study of endostar subcutaneous injection in nsclc

Conditions: NSCLC

Summary: this is an open-label, single-arm study to assess the safety, tolerability and pharmacokinetics of endostar subcutaneous injection in chinese advanced nsclc patients.


Eligibility criteria:
inclusion criteria: * histological/cytological confirmed unresectable stage ⅲb～ⅳ non-squamous nsclc * ecog performance status 0-1 * life expectancy≥3 months * adequate hematologic function: wbc≥3.0×109/l ,anc≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l; * adequate hepatic and renal function: alt≤2.5×uln, ast≤2.5×uln, tbil≤1.5×uln, creatinine≤1×uln, creatinine clearance≥50ml/min; * normal coagulation function (pt, aptt, tt, fbg) ; * patients signed informed consent form; * willingness and capability to comply with protocol requirement and well communicate with investigators. exclusion criteria: * with uncontrolled ascites or pleural effusion; * patients receiving a chest or abdominal surgery within 28 days before enrollment; or with not fully healed surgical incision; or expected to receive surgery during the study; * history of ischemic or tia within 6 months before enrollment; * uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy; * arrhythmias need to be treated; history of coronary artery disease (including angina pectoris and myocardial infarction) or ischemic myocardium; congestive heart-failure nyha class ≥ ii； * serious active infections; * history of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment; * symptomatic brain or meningeal metastasis; * epileptic seizure need to be treated; * hcv, hbv or hiv positive; * history of other malignant tumors within 5 years (except curable cervix carcinoma in situ or skin basal cell carcinoma); * known allergies to any excipient in the study drug; * any conditions that may interfere with the patient's participation in the study or have an impact on the assessment of the results of the study; * any conditions that may endanger patient safety or interfere with the patient's compliance; * pregnant and lactating women; * the investigators consider the patients unsuitable for this trial
the flip-1 study: vaginal lactobacillus supplementation in women at high risk of preterm birth

Conditions: Preterm Labor; Preterm Birth; Preterm Premature Rupture of Membrane; Cervical Incompetence; Miscarriage in Second Trimester; Miscarriage in Third Trimester

Summary: preterm birth (ptb) is the primary cause of infant death worldwide. it has been shown that a vaginal microbiota deplete in lactobacillus species is a risk factor for preterm labour. conversely a vaginal microbiota dominated by lactobacillus crispatus appears to be protective for these adverse outcomes. a wide range of 'over the counter' lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of lactobacillus. the primary aim of this study is to determine whether vaginal supplementation with l. crispatus ctv-05 is associated with colonisation.

pregnant women at queen charlotte's and chelsea hospital and st mary's hospital london who are defined as being at a higher than background risk for preterm labour will be recruited into this study. women at risk of pre-term labour will include those with either previous lletz, previous preterm birth, previous second trimester pregnancy loss or a combination of these indications. as part of this interventional study, subjects will be offered supplementation with l. crispatus ctv-05. the preparation of lactin-v is administered vaginally using a specially designed applicator. the primary aim of this study is to determine whether vaginal supplementation with l. crispatus ctv-05 is associated with colonisation.

Eligibility criteria:
inclusion criteria: * women at risk of preterm labour * women referred to the prematurity clinic * women with previous lletz (large loop excision of the transformation zone) * women with previous preterm birth * women with previous second trimester loss exclusion criteria: * hiv positive women * women who are unable to provide informed consent * women aged \<18 * women receiving antibiotic treatment within 1 week of recruitment

Keywords: pregnancy preterm labour preterm delivery vaginal microbiome infection next generation sequencing lactobacillus
midregional proatrial natriuretic peptide to guide secondary stroke prevention

Conditions: Stroke, Ischemic

Summary: the present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of mrproanp concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (doac) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.

three doacs with marketing authorisation in switzerland and the eu for the prevention of stroke and systemic embolism in patients with atrial fibrillation can be used. eligible patients will be randomly assigned to either the standard of care (control) or the experimental (direct start with doac) arm with a ratio of 1:1. each study participant will be observed during a follow up period within one year after index stroke.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ischemic stroke * level ≥200pmol/l within 72 hours from symptom onset * age ≥ 18 years * signed informed consent exclusion criteria: * history of af, af on 12-lead ecg on admission or any af ≥30 seconds during heart-rhythm monitoring prior to randomization * other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per investigator's judgment including therapeutical dose of low-molecular-weight heparin or heparin * strong likelihood to be treated with prolonged (i.e. more than 30 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.) * patients undergoing planned procedures where therapy with a doac is a contraindication (e.g. surgery) * previous intracranial hemorrhage in the last year * evidence of severe cerebral amyloid angiopathy if mri scan performed * chronic kidney disease with creatinin clearance \<30ml/min and or subject who requires haemodialysis or peritoneal dialysis * known bleeding diathesis (e.g. active peptic ulcer disease , platelet count \< 100'000/mm3 or haemoglobin \< 9 g/dl or inr ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias) * active infective endocarditis * ct or mri evidence of cerebral vasculitis * known allergy or intolerance to antiplatelets or doacs * female who is pregnant or lactating or has a positive pregnancy test at time of admission * current participation in another drug trial
68ga-psma-11 pet for the diagnosis of biochemically recurrent prostate cancer

Conditions: Biochemically Recurrent Prostate Carcinoma

Summary: this phase i trial studies the side effects of 68ga-psma-11 pet imaging in patients with prostate cancer that has come back (recurrent). gallium (68ga) is a radiotracer that binds to a molecule, psma, that is found in abundance on most prostate cancer cells. psma is short for 'prostate specific membrane antigen'. diagnostic procedures, such as 68ga-psma-11 pet imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.

primary objective: i. to provide clinical access to and assess the safety of the investigational agent gallium ga 68-labeled prostate specific membrane antigen (psma)-11 (68ga-psma-11) positron emission tomography (pet) at city of hope national medical center for patients co-enrolled on institutional review board (irb) 18517 treatment trial. outline: patients receive gallium ga 68-labeled psma-11 intravenously (iv) over less than 1 minute, and then undergo pet over 60 minutes. after completion of study, patients are followed up at 1-3 days, and then at 3 weeks.

Eligibility criteria:
inclusion criteria: * biochemical recurrent prostate cancer * karnofsky performance status of \>= 50 * the effects of 68ga-psma-11 on the developing fetus are unknown. for this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential * co-enrollment on irb 18517 * documented informed consent of the patient. all subjects must have the ability to understand and the willingness to sign a written informed consent exclusion criteria: * patients should not have any uncontrolled illness including ongoing or active infection * history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68ga-psma-11 * use of another concomitant investigational therapy (with the exception of the investigational treatment given in irb 18517) for prostate cancer within 7 days of scheduled 68ga-psma-11 pet scan * unable to tolerate pet scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes) * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
sex differences in reflex responses to intermittent hypoxia

Conditions: Healthy Participants

Summary: the purpose of the present study is to determine whether there are sex differences in the reflex responses to hypoxia in humans.

over 35% of the us population will develop sleep apnea at some point in their life. sleep apnea is the most common form of sleep disordered breathing and patients with sleep apnea are at increased risk of developing high blood pressure. intermittent, repeated exposures to low oxygen during sleep (intermittent hypoxia, ih) has been implicated as the primary stimulus for increases in sympathetic nervous system activity and blood pressure with sleep apnea. interestingly there are some reports of a lower incidence of hypertension in women with sleep apnea when compared to men. results from the present study will provide information important to the investigator's understanding of potential sex-differences in clinical outcomes for conditions related to acute/chronic hypoxia and may have important implications for treatments which may improve blood pressure control in patients with sleep apnea.

Eligibility criteria:
inclusion criteria: * healthy adult men and women; * bmi \<30 kg/m2; * non-pregnant; * non-breastfeeding; * non-smokers; * premenopausal women with a normal menstrual cycle unaffected by hormonal contraceptive use; * taking no medications known to affect autonomic or cardiovascular function (pi discretion). exclusion criteria: * taking any medications known to affect the cardiovascular or autonomic nervous system (e.g. alpha-blockers, beta-blockers, etc); * a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological diseases; * stroke or neurovascular disease; * bleeding/clotting disorder; * sleep apnea or other sleep disorders; * diabetes; * smoking; * history of alcoholism or substance abuse; * hypertension.